Trial Outcomes & Findings for Sulforaphane to Reduce Symptoms of Schizophrenia (NCT NCT02810964)
NCT ID: NCT02810964
Last Updated: 2021-07-27
Results Overview
The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
16 weeks (week 2 to week 18)
Results posted on
2021-07-27
Participant Flow
We enrolled n=64 participants drawn from rehabilitation and treatment programs in Central Maryland. Dates of recruitment: February 2017 - June 2019.
We used a 2 week single-blind placebo phase for all participants prior to randomization. This placebo run-in was followed by the 16 week double-blind treatment phase.
Participant milestones
| Measure |
Sulforaphane Nutraceutical
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
|
Identical-appearing Placebo
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
|
|---|---|---|
|
Placebo Run-In Phase (2 Weeks)
STARTED
|
32
|
32
|
|
Placebo Run-In Phase (2 Weeks)
COMPLETED
|
32
|
32
|
|
Placebo Run-In Phase (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Double-Blind Treatment Phase (16 Weeks)
STARTED
|
32
|
32
|
|
Double-Blind Treatment Phase (16 Weeks)
COMPLETED
|
29
|
29
|
|
Double-Blind Treatment Phase (16 Weeks)
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Sulforaphane Nutraceutical
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
|
Identical-appearing Placebo
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
|
|---|---|---|
|
Double-Blind Treatment Phase (16 Weeks)
Withdrawal by Subject
|
1
|
2
|
|
Double-Blind Treatment Phase (16 Weeks)
Lost to Follow-up
|
1
|
0
|
|
Double-Blind Treatment Phase (16 Weeks)
Protocol Violation
|
0
|
1
|
|
Double-Blind Treatment Phase (16 Weeks)
Relocation
|
1
|
0
|
Baseline Characteristics
Sulforaphane to Reduce Symptoms of Schizophrenia
Baseline characteristics by cohort
| Measure |
Sulforaphane Nutraceutical
n=32 Participants
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
|
Identical-appearing Placebo
n=32 Participants
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
64 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 12.3 • n=93 Participants
|
45.8 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
44.2 years
STANDARD_DEVIATION 12.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
18 participants
n=93 Participants
|
16 participants
n=4 Participants
|
34 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African American
|
14 participants
n=93 Participants
|
16 participants
n=4 Participants
|
30 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=93 Participants
|
32 participants
n=4 Participants
|
64 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 16 weeks (week 2 to week 18)The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale.
Outcome measures
| Measure |
Sulforaphane Nutraceutical
n=29 Participants
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
|
Identical-appearing Placebo
n=29 Participants
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
|
|---|---|---|
|
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase
Wk 2 (Begin Treatment) PANSS Total Score
|
81.0 score on a scale
Standard Deviation 12.2
|
81.5 score on a scale
Standard Deviation 13.0
|
|
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase
Wk 18 (End Treatment) PANSS Total Score
|
81.7 score on a scale
Standard Deviation 13.3
|
79.7 score on a scale
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: 18 weeks (week 0 to week 18)The MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) Consensus Cognitive Battery (MCCB) is a standardized battery of 10 tests that measure 7 domains of cognitive performance: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. Overall composite t-scores are calculated using scores from all subtests. A t-score of 50 (10) is the mean (standard deviation) of the relevant reference population. Higher values indicate better performance.
Outcome measures
| Measure |
Sulforaphane Nutraceutical
n=29 Participants
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
|
Identical-appearing Placebo
n=29 Participants
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
|
|---|---|---|
|
Change in MATRICS Consensus Cognitive Battery (MCCB) Overall Composite Scores From the Start to the End of the Study
Wk 0 (Baseline) MCCB Score
|
25.0 t scores
Standard Deviation 12.0
|
19.5 t scores
Standard Deviation 13.4
|
|
Change in MATRICS Consensus Cognitive Battery (MCCB) Overall Composite Scores From the Start to the End of the Study
Wk 18 (End Treatment) MCCB Score
|
26.8 t scores
Standard Deviation 12.6
|
22.8 t scores
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)Outcome measures
| Measure |
Sulforaphane Nutraceutical
n=29 Participants
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
|
Identical-appearing Placebo
n=29 Participants
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
|
|---|---|---|
|
Change in C-Reactive Protein From the Start to the End of the Study
CRP (Wk 0, Baseline)
|
10402.8 ng/ml
Standard Deviation 13488.2
|
8969.7 ng/ml
Standard Deviation 9021.6
|
|
Change in C-Reactive Protein From the Start to the End of the Study
CRP (Wk 18, End Treatment)
|
10198.5 ng/ml
Standard Deviation 12110.9
|
10224.5 ng/ml
Standard Deviation 13654.0
|
SECONDARY outcome
Timeframe: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)Outcome measures
| Measure |
Sulforaphane Nutraceutical
n=29 Participants
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
|
Identical-appearing Placebo
n=29 Participants
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
|
|---|---|---|
|
Change in Pentraxin-3 From the Start to the End of the Study
Pentraxin(Wk 0, Baseline)
|
0.414 ng/ml
Standard Deviation 0.534
|
0.461 ng/ml
Standard Deviation 0.603
|
|
Change in Pentraxin-3 From the Start to the End of the Study
Pentraxin (Wk 18, End Treatment)
|
0.394 ng/ml
Standard Deviation 0.569
|
0.558 ng/ml
Standard Deviation 0.695
|
SECONDARY outcome
Timeframe: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)Outcome measures
| Measure |
Sulforaphane Nutraceutical
n=29 Participants
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
|
Identical-appearing Placebo
n=29 Participants
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
|
|---|---|---|
|
Change in Anti-Saccharomyces Cerevisiae IgA Class Antibodies From the Start to the End of the Study
ASCA IGA (Wk 0, Baseline)
|
0.195 units/ml
Standard Deviation 0.222
|
0.168 units/ml
Standard Deviation 0.163
|
|
Change in Anti-Saccharomyces Cerevisiae IgA Class Antibodies From the Start to the End of the Study
ASCA IGA (Wk 18, End Treatment)
|
0.226 units/ml
Standard Deviation 0.277
|
0.176 units/ml
Standard Deviation 0.184
|
SECONDARY outcome
Timeframe: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)Outcome measures
| Measure |
Sulforaphane Nutraceutical
n=29 Participants
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
|
Identical-appearing Placebo
n=29 Participants
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
|
|---|---|---|
|
Change in Interleukin-6 From the Start to the End of the Study
IL-6 (Wk 18, End Treatment)
|
0.694 pg/m
Standard Deviation 0.288
|
0.673 pg/m
Standard Deviation 0.357
|
|
Change in Interleukin-6 From the Start to the End of the Study
IL-6 (Wk 0, Baseline)
|
0.623 pg/m
Standard Deviation 0.247
|
0.704 pg/m
Standard Deviation 0.478
|
SECONDARY outcome
Timeframe: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)Outcome measures
| Measure |
Sulforaphane Nutraceutical
n=29 Participants
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
|
Identical-appearing Placebo
n=29 Participants
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
|
|---|---|---|
|
Change in Tumor Necrosis Factor - Alpha From the Start to the End of the Study
TNF-a (Wk 0, Baseline)
|
0.668 pg/m
Standard Deviation 0.393
|
0.538 pg/m
Standard Deviation 0.211
|
|
Change in Tumor Necrosis Factor - Alpha From the Start to the End of the Study
TNF-a (Wk 18, End Treatment)
|
0.638 pg/m
Standard Deviation 0.362
|
0.520 pg/m
Standard Deviation 0.263
|
SECONDARY outcome
Timeframe: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)Outcome measures
| Measure |
Sulforaphane Nutraceutical
n=29 Participants
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
|
Identical-appearing Placebo
n=29 Participants
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
|
|---|---|---|
|
Change in Interferon Gamma From the Start to the End of the Study
IFN-g (Wk 0, Baseline)
|
0.514 pg/m
Standard Deviation 0.432
|
0.456 pg/m
Standard Deviation 0.172
|
|
Change in Interferon Gamma From the Start to the End of the Study
IFN-g (Wk 18, End Treatment)
|
0.478 pg/m
Standard Deviation 0.335
|
0.526 pg/m
Standard Deviation 0.222
|
Adverse Events
Sulforaphane Nutraceutical
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Identical-appearing Placebo
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sulforaphane Nutraceutical
n=32 participants at risk
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
|
Identical-appearing Placebo
n=32 participants at risk
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
|
|---|---|---|
|
Psychiatric disorders
Schizophrenia exacerbation
|
6.2%
2/32 • Number of events 2 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
6.2%
2/32 • Number of events 3 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
|
Gastrointestinal disorders
Cholecystitis
|
0.00%
0/32 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
|
Musculoskeletal and connective tissue disorders
Knee replacement
|
0.00%
0/32 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
|
Cardiac disorders
Congestive heart failure
|
0.00%
0/32 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
Other adverse events
| Measure |
Sulforaphane Nutraceutical
n=32 participants at risk
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
|
Identical-appearing Placebo
n=32 participants at risk
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptoms
|
37.5%
12/32 • Number of events 15 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
28.1%
9/32 • Number of events 9 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
|
Cardiac disorders
Cardiovascular symptoms
|
3.1%
1/32 • Number of events 1 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
9.4%
3/32 • Number of events 3 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
37.5%
12/32 • Number of events 15 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
18.8%
6/32 • Number of events 8 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.2%
2/32 • Number of events 2 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
9.4%
3/32 • Number of events 3 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
|
Endocrine disorders
Endocrine/metabolic symptoms
|
12.5%
4/32 • Number of events 4 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
21.9%
7/32 • Number of events 8 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
|
Skin and subcutaneous tissue disorders
Dermatological symptoms
|
12.5%
4/32 • Number of events 5 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
0.00%
0/32 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
|
Renal and urinary disorders
Urinary symptoms
|
6.2%
2/32 • Number of events 2 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
9.4%
3/32 • Number of events 3 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
|
Psychiatric disorders
Psychiatric symptoms
|
34.4%
11/32 • Number of events 14 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
15.6%
5/32 • Number of events 11 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
|
Blood and lymphatic system disorders
Hematological symptoms
|
3.1%
1/32 • Number of events 1 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
0.00%
0/32 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
|
General disorders
Other
|
12.5%
4/32 • Number of events 4 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
15.6%
5/32 • Number of events 5 • Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place